12 results · 22ms · Sources: EU EUDAMED, US FDA

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ACTHK-PR RIA KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78603111·Sprint II Bracket Roth .022" max. 3 right

Shoreline ACS

FDA UDI
Seaspine Orthopedics Corporation·10889981127350·18x15x11mm, 7 Degree Trial

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78603110051·Sprint II Bracket Roth .022" max. 3 right

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78603111001·Sprint II Bracket Roth .022" max. 3 right

Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78603110101·Sprint II Bracket Roth .022" max. 3 right

EPILONG KIT FOR ANESTHESIOLOGY

FDA 510(k)
FDA Class 2 ·Anesthesiology

INSTRUMENTS, GENERAL HAND & SURGERY

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

ATTAIN ABILITY

FDA Adverse Event
Malfunction ·MPRI·Product code OJX·June 10, 2014

SETROX S 53

FDA Adverse Event
Other ·BIOTRONIK SE & CO. KG·Product code NVZ·November 21, 2012

PROTIME MICROCOAGULATION SYSTEM

FDA Adverse Event
Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·September 23, 2010

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012